Drug application
IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER (DEXTROSE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE and 3 more)
Drugs@FDA NDA 019513 · OTSUKA ICU MEDCL
Key facts
| Drug name | IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER |
|---|---|
| Active ingredients | DEXTROSE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, SODIUM LACTATE, SODIUM PHOSPHATE, MONOBASIC ANHYDROUS |
| Application type | NDA |
| Application number | 019513 |
| Company | OTSUKA ICU MEDCL |
| Dosage forms | INJECTABLE, INJECTION |
| Strength | 5GM/100ML;30MG/100ML;141MG/100ML;15MG/100ML;260MG/100ML;25MG/100ML |
| Marketing status | Prescription |
| Reference listed drug | No |
| Latest submission class | Type 5 - New Formulation or New Manufacturer |
| Latest submission status date | May 8, 1986 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.